Senior Regulatory Affairs Associate

Key Accountabilities

Project Execution

• Works effectively in teams or independently within area of competence
• Works within project guidelines as directed by project/technical leads
• Prioritizes work to achieve project outcomes
• Seeks performance improvement and feedback
• Applies information from senior colleagues to complete assigned activities
• Produces quality work meeting project lead and client expectations
• May serve as Project Lead for small projects or Work Stream Lead on larger projects
• Functions as main client contact and ensures accurate project reporting
• Ensures team delivery meets client expectations for quality and timeliness
• Implements risk identification and issue-escalation procedures
• Ensures project-specific training compliance
• Manages project financials including revenue forecasts
• Ensures team works within contract scope
• Identifies new opportunities through Change In Scope or add-on business
• Ensures timely project close-out
  

Consulting Activities and Relationship Management

• Implements consulting models and methodologies under guidance
• Delivers services within personal expertise area
• Completes activities within project scope with understanding of profitability impacts
• Identifies issues and proposes solutions
• Interacts professionally at all levels within client organization and Parexel
• Identifies project/client needs and collaborates on solutions
• Maintains client satisfaction
• May assist with presentations with senior colleague support
• Identifies follow-on business opportunities or necessary scope changes
  

Regulatory Responsibilities

• Stay updated on local and regional regulatory requirements and guidelines
• Ensure compliance with evolving regulations
• Communicate requirements to GRA and local staff
• Participate in regulatory meetings, forums, and conferences
• Share insights and best practices within the organization
  

Dossier Management

• Review and submit dossiers
• Negotiate with Health Authorities on approvals
• Work with local Regulatory, Medical, Marketing, and Market Access teams to support impact of changes
  

Required Skills

• Project management knowledge
• Client-focused approach
• Results orientation
• Teamwork and collaboration
• Excellent interpersonal and intercultural communication
• Critical thinking and problem-solving
• Proficiency in local language and extensive English knowledge
  

Required Qualifications

• Bachelor's Degree in Scientific or Technical Discipline
• 4+ years of experience in an industry-related environment